Apparatus and methods for performing brain surgery

ABSTRACT

Less invasive surgical techniques for performing brain surgery are disclosed in which a dilating obturator and cannula assembly is inserted into brain tissue until the obturator tip and cannula are adjacent to the target tissue. The obturator is removed and surgery is performed through the cannula. In preferred embodiments the obturator and cannula are placed using image guidance techniques and systems to coordinate placement with pre-operative surgical planning. A stylet with associated image guidance may be inserted prior to insertion of the obturator and cannula assembly to guide insertion of the obturator and cannula assembly. Surgery preferably is performed using an endoscope partially inserted into the cannula with an image of the target tissue projected onto a monitor. Dilating obturator structures having a rounded or semi-spherical tip and/or an optical window for visualizing brain tissue during expansion are contemplated.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/665,667, filed Apr. 18, 2007, which is a national stage applicationof international application serial no. PCT/US2005/038828, filed Oct.28, 2005, which claims the benefit of U.S. provisional application Ser.No. 60/622,991, filed Oct. 28, 2004, the entire contents of each ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to methods of accessing and performingsurgery within the brain.

BACKGROUND

Diagnosis and treatment of conditions affecting the brain are among themost difficult and complex problems that face the medical profession.The brain is a delicate soft tissue structure that controls bodilyfunctions through a complex neural network connected to the rest of thebody through the spinal cord. The brain and spinal cord are containedwithin and protected by significant bony structures, e.g., the skull andthe spine. Given the difficulty of accessing the brain through the hardbony protective skull the diagnosis and treatment of brain disorderspresents unique challenges not encountered elsewhere in the body.

Diagnosis of brain disorders requires clear, accurate imaging of braintissue through the skull. In recent years significant advances have beenmade in imaging technology, including stereotactic X-ray imaging,Computerized Axial Tomography (CAT), Position Emission Tomography (PET)and Magnetic Resonance Imaging (MRI). See, for example, Butler U.S. Pat.No. 6,359,959. These imaging devices and techniques permit the surgeonto examine conditions within the brain in a non-invasive manner withoutopening the skull. If a target lesion or mass is identified through useof one or more imaging techniques, it may be necessary or desirable tobiopsy a lesion within the brain. Stereotactic techniques and apparatusfor directing a biopsy needle to the site are described and shown, forexample, in Cosman U.S. Pat. Nos. 6,331,180 and 6,416,520.

Once a diagnosis has been reached based upon one or more imagingtechniques, a treatment plan must be developed. One available method oftreatment involves X-ray therapy such as disclosed in Leber U.S. Pat.No. 5,513,238; Shiu U.S. Pat. No. 5,555,283; Cosman U.S. Pat. Nos.5,748,703, 5,778,043, 5,947,981, 6,459,769; and Kooy U.S. Pat. Nos.6,005,919, 6,041,101, and 6,278,766. Alternatively, surgical treatmentmay be necessary or desired. In order to operate surgically on thebrain, access must be obtained through the skull and delicate braintissue containing blood vessels and nerves that can be adverselyaffected by slight disturbances. Therefore, great care must be taken inoperating on the brain not to disturb delicate blood vessels and nervesso that adverse consequences do not result during or after surgery.Brain surgery can be highly invasive. In some instances, in order toobtain access to target tissue, a substantial portion of the skull isremoved and entire sections of the brain are retracted to obtain access.Of course, such techniques are not appropriate for all situations, andnot all patients are able to tolerate and recover from such invasivetechniques. It is also known to access certain portions of the brain byforming a hole in the skull, but only limited surgical techniques may beperformed through such smaller openings. In addition, some techniqueshave been developed to enter through the nasal passages, opening anaccess hole through the occipital bone to remove tumors located, forexample, in the area of the pituitary.

A significant advance in brain surgery is stereotactic surgery involvinga stereotactic frame correlated to stereotactic X-ray images to guide aprobe or other surgical instrument through an opening formed in theskull through brain tissue to a target lesion or other body. See, forexample, U.S. Pat. Nos. 6,331,180 and 6,416,520. A related advance isframeless image guidance, in which an image of the surgical instrumentis superimposed on a pre-operative image to demonstrate the location ofthe instrument to the surgeon and trajectory of further movement of theprobe or instrument. Image guided surgery is described, for example, inGuthrie U.S. Pat. Nos. 5,230,623, 5,971,997, 6,120,465, and 6,409,686;Cosman U.S. Pat. Nos. 5,662,111, 5,848,967, 6,006,126, 6,167,295,6,259,943, 6,275,725, 6,351,661, 6,405,072, 6,662,036, and 6,675,040;and Faro U.S. Pat. Nos. 5,251,127, 5,305,203, and 5,748,767.

Kassam published U.S. patent application 2008/0109026 proposes alternatemethods and devices for performing brain surgery involving inserting acannula with a dilating obturator into the brain to gently dilate thebrain tissue. The cannula and dilating obturator may be inserted underimage guidance. The cannula provides access to tissue within the brainand provides a working space for the surgeon to perform surgery onstructures of the brain, preferably using an endoscope partiallyinserted into the cannula to visualize the operative site at the end ofthe cannula. The image from the endoscope may be projected onto amonitor or screen to assist the surgeon and others to visualize thestructures of the brain. The present disclosure provides alternativestructures and techniques useful in performing surgery in accordancewith the techniques disclosed, described or shown in the foregoingapplication.

Dubrul U.S. Pat. Nos. 5,183,464 and 5,431,676 disclose and describeexpandable dilators or trocars useful for accessing hollow body organs.Structures similar to those described by Dubrul have been marketed andsold for laparoscopic access under the trademark STEP by Innerdyne,Inc., and subsequently by the AutoSuture Division of Tyco HealthcareGroup, LP (Norwalk, Conn.). Expandable cannula structures havinglongitudinal wire also are disclosed and described in Bonutti U.S. Pat.No. 5,320,611.

Urban U.S. Pat. No. 5,860,996 discloses and describes an optical trocarfor use in laparoscopic surgical procedures. The optical trocar includesa movable cutting blade extendable from a rounded optical window at thedistal tip as penetration through tissue is observed through anendoscope inserted into a sleeve until the tip of the endoscope isadjacent to the window. Optical trocars have been marketed forlaparoscopic access under the trademark VISIPORT by the AutoSutureDivision of Tyco Healthcare Group, LP (Norwalk, Conn.). Penetratingoptical trocars also are shown and described in Kaali U.S. Pat. Nos.5,334,150, 5,376,076, 5,380,291, 5,551,947, 5,609,562, and 5,702,761;Sauer U.S. Pat. Nos. 5,441,041, 5,467,762, 5,569,160, and 6,685,630;Reik U.S. Pat. Nos. 5,271,380, 5,431,151, 5,685,820, and 6,007,481; andHassler U.S. Pat. No. 5,445,142.

SUMMARY

Apparatus and methods are disclosed for atraumatically dilating braintissue to access target tissue within the brain.

A first apparatus for accessing brain tissue has a dilating obturatorwith a blunt rounded distal tip, a substantially cylindrical shaftportion, and a proximal handle portion. A cannula is disposed around theshaft portion and preferably is made of a transparent material. Theobturator and cannula assembly preferably is associated with animage-guided surgery system so that placement of the obturator andcannula assembly can be carefully monitored and controlled as theobturator and cannula assembly is atraumatically inserted into braintissue.

In a first embodiment of such an apparatus the obturator has alongitudinal channel therethrough configured and dimensioned to receivethe shaft of a narrow stylet or probe. The stylet or probe has attachedthereto image guidance means calibrated to indicate the orientation andposition of the stylet or probe. An image guidance system interacts withthe stylet or probe to display for the surgeon on a monitor an image ofthe stylet or probe superimposed onto an image of the patients brain,such as an MRI image. The image may be a pre-operative MRI image usedfor surgical planning. When the stylet or probe is mounted in thelongitudinal channel of the obturator, the superimposed image of theprobe also is indicative of the position and orientation of the dilatingobturator and the cannula.

Traditional methods are used to incise and retract soft tissue of thescalp covering the skull. A hole is made in the skull, and the dura isopened and retracted to provide access to the brain. The stylet or probeis inserted through the obturator longitudinal channel and advanceduntil a length of the stylet or probe extends out of and beyond theblunt rounded tip of the dilating obturator. The dilating obturator andcannula assembly is held back away from the tissue as the stylet orprobe is gently advanced through the brain tissue under both directvision and positional image guidance until the tip of the stylet orprobe is adjacent the target tissue. Once the stylet or probe is placedand the position is confirmed using the image guidance system, the bluntrounded dilating obturator and cannula assembly is slowly and carefullyadvanced into the brain tissue to atraumatically spread the tissue overthe dilating tip and around the cannula while maintaining the positionof the stylet or probe as a guide to advancement of the obturator andcannula assembly. A gentle back and forth rotation during insertion mayfacilitate placement of the obturator and cannula assembly. Once thedilating obturator and cannula assembly are correctly positionedadjacent the target tissue, the stylet or probe and dilating obturatorare removed, leaving the cannula in place to support and protect thedilated brain tissue. Preferably, the cannula is clear so that thedilated brain tissue may be visually inspected through the walls of thecannula to assure that no damage was caused to surrounding brain tissueduring insertion of the device.

Alternatively, in a second contemplated embodiment of such an apparatusthe image guidance means may be mounted directly to the dilatingobturator and cannula assembly so that the obturator and cannulaassembly may be inserted without a separate stylet or probe. In thisconfiguration, the obturator and cannula assembly is inserted into thebrain tissue under image guidance until the obturator is adjacent thetarget tissue. Once the obturator and cannula assembly is positioned,the dilating obturator is removed, leaving the cannula in place.

In yet a third contemplated embodiment of such an apparatus, thedilating obturator and cannula assembly may be inserted into the brainunder direct visualization without use of an image guidance system.

In yet a fourth alternative embodiment a tissue dilator has an opticalwindow at the tip thereof and is configured and dimensioned to receivean endoscope or like device such that the user may visualize braintissue as the dilator is inserted directly into the brain. The opticaldilator is surrounded by a cannula, and may optionally also have alongitudinal channel to receive a stylet or probe. The optical dilatingobturator and cannula assembly may be inserted into the brain underdirect visualization, and progress through brain tissue may be observedduring insertion either directly through the endoscope or by projectingthe image from the endoscope onto a monitor or screen. The opticaldilator and cannula assembly may be provided with identifying indiciacompatible with an image guidance system such that the optical dilatingobturator and cannula may be inserted utilizing both visualization ofbrain tissue and image guidance. Alternatively, the optical dilator maybe provided with an auxiliary channel configured and dimensioned toreceive a stylet or obturator, such that the stylet may be inserted intothe brain to the target tissue under image guidance, with the opticalobturator used to visualize the brain tissue as the optical obturatorand cannula assembly is inserted over the stylet to reach the targettissue. After the optical obturator and cannula assembly is inserted tothe desired location the optical dilator, stylet (if used) and endoscopemay be removed, leaving the cannula in place to provide access and aworking space to the surgeon. The same or another endoscope maythereafter be mounted partially extending through the cannula to providevisualization of the target tissue at the end of the cannula forsurgery. Alternatively, optics may also be incorporated directly intothe optical dilator, or an endoscope may be inserted through the cannulasuch that the endoscope acts as the dilator.

After the cannula is placed, surgery may be performed through thecannula, either under direct vision or more preferably using anendoscope and camera system to project an enlarged image of the targettissue onto a monitor to visualize the tissue during surgery.

Preferably, the cannula has a diameter of approximately 10 mm to 20 mm,and more preferably 10 mm to 15 mm. An endoscope of a substantiallysmaller diameter, such as a 4 mm endoscope, is mounted partiallyinserted into the cannula. The endoscope is mounted to one side of thecannula and inserted so that the image projected onto the monitor is ofthe target tissue at the end of the cannula. In practice, a 4 mmendoscope is inserted approximately halfway into the cannula isappropriate to create the desired image display while leaving asubstantial portion of the cannula open and available for the insertionof instruments to perform surgery. Optionally, a camera holder may beused to secure the endoscope in the desired position.

Appropriate surgical instruments are then used to perform surgery uponthe target tissue. For example, scissors, graspers and suction tools maybe inserted through the cannula, visualizing the tips of the instrumentsto perform the desired procedure either directly with the naked eye orthrough a microscope, or indirectly through the endoscope using theendoscope eyepiece or more preferably and camera system to display theimage on a monitor. A preferred instrument for debulking brain tissue isa fluidized ultrasonic instrument, such as CUSA (Valleylab, BoulderColo.). Monitoring equipment may be used to monitor brain functionduring surgery to assist the surgeon in understanding the effects of theactions taken during surgery on the brain so that the surgery may beterminated in the event an indication of an adverse effect is detected.

After surgery upon the target tissue is complete, the cannula is gentlyremoved, and the dura, skull and scalp are closed in a traditionalfashion.

In an alternative apparatus, a stylet or probe is inserted into thebrain, preferably under image guidance, until the tip of the probe isadjacent target tissue within the brain. The stylet is surrounded by anexpandable sleeve extending substantially the entire length of thestylet or probe which is inserted into the brain together with thestylet or probe. An expanding dilator and cannula assembly is theninserted into the expandable sleeve to atraumatically expand the sleeveto the diameter of the cannula, thereby atraumatically dilating thebrain tissue surrounding the expandable sleeve to accommodate thecannula. In one such embodiment, the dilator and cannula assembly isinserted over the stylet with the stylet extending through alongitudinal passage provided for that purpose through the dilator.Alternatively, it is contemplated that the stylet or probe may beremoved prior to inserting the dilator and cannula assembly, such thatthe expandable sleeve remains as placed in the brain using the stylet,ready to receive and guide the dilator and cannula assembly. Theexpandable sleeve may be attached to a hub, with the cannula and dilatorinserted through the hub into the expandable sleeve. Alternativevariations of the dilating tip and cannula are contemplated. By way ofexample only, the dilating obturator may have a blunt conical tip or asemi-spherical, curved or other outer surface configured to expand theexpandable sleeve to the diameter of the cannula without requiring undueforce or traumatizing surrounding tissue. A substantially flat orslightly curved tip surface may suffice depending upon the ratio of theunexpanded sleeve to the cannula diameter.

In a further alternative embodiment, it is contemplated that a radiallydilating structure may be used rather than a dilator that utilizeslongitudinal insertion to expand the sleeve. In one radially expandableconfiguration segments of cannula wall are moved into a configuration todefine a cannula, and may become self-supporting in such configurationor may be locked into such position by one or more locking elements.

Another radial expansion device involves a braid structure that iscompressed so that the resulting decrease in braid angle causes thetubular or other shaped braid to expand. Such a radially expanding braidmay be used to expand the expandable sleeve or may be incorporateddirectly into and become part of the expandable sleeve.

In yet a further alternative embodiment the cannula is inserted into theexpandable sleeve without a dilating obturator.

In yet a further alternative embodiment the dilating obturator to beinserted into the expandable sleeve may have a clear or transparentwindow at the tip, with a longitudinal channel configured anddimensioned to receive an endoscope. In this manner, as the dilator isinserted through the expandable sleeve, the surgeon may view the braintissue being dilated, and may immediately visualize the target tissueafter the dilating tip has been inserted to the desired depth. Theoptical dilator may optionally include a longitudinal channel to receivethe stylet or probe.

In all of the contemplated embodiments, the surgeon is provided with acannula which is atraumatically inserted and which atraumaticallyretracts brain tissue to provide access and working space sufficient toallow the surgeon to perform surgery on the target brain tissue. Whilethe cannula is shown and described as cylindrical, it is alsocontemplated that the cannula may have a non-circular cross-section,such as square, rectangular, elliptical, oval or other shape as may benecessary or desirable under particular circumstances.

The devices and methods disclosed herein provide numerous advantages inperforming brain surgery. Gentle atraumatic dilation of the brain tissuemakes it possible to operate further inside the brain than otherwisewould be possible utilizing traditional surgical techniques. Thedisclosed methods and apparatus create an access area to work whilesimultaneously protecting adjacent brain tissue from inadvertentcollateral damage and trauma that might otherwise occur if moretraditional surgical techniques were to be utilized. In addition,accessing target tissue through the cannula as contemplated avoids moreinvasive techniques that involve removing substantial portions of theskull and retracting large portions of the brain to gain access tooperate on target tissues. In some cases, the devices and methods maymake it possible to operate on target tissue that would, without thesedevices and methods, otherwise be regarded as inoperable usingpreviously known techniques.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings form a part of this disclosure, in which:

FIG. 1 is a perspective view, with parts separated, of an access devicein accordance with a first embodiment;

FIG. 2 is a cross-sectional view of an obturator and cannula assembly,with parts separated, in accordance with the first embodiment;

FIG. 3 is a perspective view of an obturator, cannula and styletassembly in accordance with the first embodiment;

FIG. 4 is a perspective view, with parts separated, of an access devicein accordance with a second embodiment;

FIG. 5 is a perspective view, with parts separated, of an access devicein accordance with a third embodiment;

FIG. 6A is a partial cross-section view of a first optical dilator withan endoscope disposed in the optical dilator;

FIG. 6B is a partial cross-section view of a second optical dilator,with a stylet extending through the dilator and an endoscope disposed inthe optical dilator;

FIG. 7 is an illustration of the first embodiment with the styletinserted to a point adjacent target tissue within the brain;

FIG. 8 is an illustration of the first embodiment with the obturator andcannula assembly partially inserted into and atraumatically separatingbrain tissue;

FIG. 9 is an illustration of the first embodiment, with the obturatorand cannula assembly inserted over the stylet to target tissue;

FIG. 10 is an illustration of a cannula in place holding brain tissueapart to provide access to target tissue;

FIG. 11 is an illustration of an endoscope mounted partially within thecannula and a scissors and suction device inserted to debulk and removetarget tissue;

FIG. 12 is an illustration of a cannula in place after target tissue hasbeen removed;

FIG. 13 is an illustration showing brain tissue having resumed itsposition occupying the space previously occupied by the cannula duringsurgery;

FIG. 14 is a perspective view of a stylet with an expandable sleeve;

FIG. 14A is a proximal end view of the expandable sleeve and hubassembly;

FIG. 15 is an illustration of the embodiment of FIG. 14 inserted intobrain tissue;

FIG. 16 is an illustration of the embodiment of FIGS. 14 and 15, withthe stylet removed and a dilating obturator and cannula assemblyinserted into and expanding the expandable cannula;

FIG. 17 is an illustration of the embodiment of FIG. 16 with thedilating obturator removed to provide a cannula in the expandable sleeveto provide access to the target tissue;

FIG. 18 is a cross-section view of an expandable sleeve device with thestylet disposed within the expandable sleeve and a dilating obturatorand cannula assembly mounted over the stylet shaft proximal to theexpandable sleeve;

FIGS. 19A and 19B are cross-section views of an expandable sleeve with aballoon-actuated radially expandable cannula;

FIGS. 20A and 20B are partial cross section views illustrating analternative structure for radially expanding an expandable sleeve; and

FIG. 21 is a cross section view of a cannula including a proximalannular flange.

DETAILED DESCRIPTION

Referring now to the drawings, FIG. 1 illustrates a first embodiment ofan apparatus 10 for accessing target tissue within the brain in order toperform brain surgery. The access device includes a cannula 12, adilating obturator 14 and a stylet or probe 16. Stylet or probe 16 has asmall diameter elongated shaft 18, a handle 20 and associated positionindicators 22 for a position guidance system. Stylet shaft 18 has ablunt tip 24 that can be inserted into and advanced through braintissue. In FIG. 1, image guidance position indicators are shown asinfrared reflectors of the type use in connection with optical imageguidance systems, although other position indicating systems could beused. As shown, the infrared reflectors used with such a system aremounted to the stylet handle in a customary triangular configurationcalibrated to identify the tool to the image guidance system. Suchimaging systems are available, for example Medtronic Surgical NavigationTechnologies (Denver, Colo.), Stryker (Kalamazoo, Mich.), and Radionics(Burlington Mass.).

Typically, the positioning of the indicator reflector balls iscalibrated such that the image guidance system recognizes the particulartool and projects an image of the tool onto a display of images of thepatients brain, such as MRI images used to plan surgery. Calibration ofinstruments to an image guidance system is disclosed, for example, inCostales U.S. Pat. No. 5,921,992. As the instrument is inserted, thesurgeon can see the relative position of the instrument relative to thestructures of the brain as reflected on images used to plan surgery,particularly with respect to the target tissue.

Dilating obturator 14 has a proximal handle portion 26, a substantiallycylindrical shaft portion 28, and a blunt dilating tip 30. Bluntdilating tip 30 is of a rounded atraumatic configuration, such as asemi-spherical dome or other gently curved surface. A longitudinalaccess channel 32 extends through the dilating obturator 14. Thelongitudinal channel is configured and dimensioned to receive shaft 18of the stylet or probe 16. Cannula 12 is substantially cylindrical andis configured to slide over and mount onto the substantially cylindricalshaft 28 of the dilating obturator 14. Leading edge 34 of cannula 12 maybe chamfered to reduce insertion force and minimize trauma duringinsertion into the brain.

FIG. 2 is a cross-section view of the cannula 12 and dilating obturator14 of the first embodiment, illustrating blunt rounded dilating tip 30of the dilating obturator 14, the chamfered lead edge 34 of cannula 12and the longitudinal access channel 32 extending axially through theentire length of the dilating obturator.

FIG. 3 is a perspective view of the first embodiment in an assembledcondition, with cannula 12 disposed over the shaft of dilating obturator14 and stylet or probe shaft 18 inserted through the longitudinal accesschannel 32 of the dilating obturator. Stylet 18 is shown projecting fromthe distal, rounded tip of the dilating obturator.

FIG. 4 is a perspective view, with parts separated, of a secondembodiment of an access device 50 for brain surgery. Access device 50includes a cannula 52 with a chamfered lead edge 54. Access device 50also includes a dilating obturator 56 having a handle portion 58, asubstantially cylindrical shaft 60 and an atraumatic blunt dilating tip62. Blunt tip 62 has a rounded distal surface, such as a semi-sphericalsurface. Cannula 52 is configured and dimensioned to mount over shaft 60of the dilating obturator. The obturator shaft is configured anddimensioned to removably fit into the cannula inner diameter and tooccupy the open space within the cannula. As shown in FIG. 4, the imageguidance identification device 64 with infrared imaging reflectors 66 isattached directly to the dilating obturator, eliminating the stylet orprobe of the first embodiment. Accordingly, the dilating obturator ofthe second embodiment also need not include the longitudinal accesschannel for the stylet or probe.

For illustration purposes devices disclosed herein are shown withinfrared reflectors as used with available optical image guidancesystems. Other guidance systems, such as magnetic or electromagnetic orradio transmitting systems may also be used, and the illustration ofinfrared reflectors and discussion of optical image guidance systems areexemplary only and are not intended to be limiting. In addition,currently available image guidance systems superimpose an image of thetool onto a pre-operative image. It is contemplated that as technologycontinues to progress that real-time imaging capability may becomeavailable in the operating room, and that the image of the tool may thenbe shown in relation to the surrounding tissue structures on a real timeimage.

FIG. 5 is a perspective view, with parts separated, of a thirdembodiment of an access device 70 for brain surgery. Access device 70includes cannula 72 with chamfered lead edge 74, and a dilatingobturator 76. Dilating obturator 76 includes a handle 78, substantiallycylindrical shaft 80 and rounded dilating tip 82, which may besemi-spherical. Access device 70 does not include apparatus forcalibrating the position of the dilating obturator with an imageguidance system or a stylet or probe for aiding insertion of thedilating obturator.

FIGS. 6A and 6B illustrate an alternative dilating obturator and cannulaassembly which may be used with the foregoing embodiments. Morespecifically, FIGS. 6A and 6B illustrate an optical dilating obturatorwhich permits visualization as the optical dilating obturator andcannula assembly is inserted into the brain.

Referring now to FIG. 6A the optical dilating obturator and cannulaassembly is configured to include a cannula 82 and a dilating obturator84 having a transparent optical window 86 at the distal end of theobturator. Preferably, the transparent optical window is rounded, suchas the semi-spherical window shown in FIG. 6A. As shown, a longitudinalchannel 88 configured and dimensioned to receive an endoscope isprovided in the obturator. An endoscope 90 is shown inserted into theendoscope channel in the dilating obturator. In use, the opticaldilating obturator and cannula assembly may be used as in the embodimentof FIGS. 4 and 5 to visualize the brain tissue as the obturator andcannula assembly is inserted into the brain. Thus, the image acquired bythe endoscope through the distal optical window may be observed as theobturator and cannula is inserted into the brain tissue. The image maybe projected onto a monitor or screen for display for visualization asthe obturator is inserted. If the optical dilating obturator and cannulaassembly is used together with an image guidance system, the position ofthe instrumentation may be displayed in one image while the optical viewthrough the endoscope is display in another.

FIG. 6B illustrates an optical dilating obturator and cannula assemblysimilar to that of FIG. 6A using like reference numerals forcorresponding structures, but configured to accommodate stylet shaft 18of the embodiment shown in FIGS. 1-3. As shown, optical dilatingobturator 84 additionally includes a longitudinal stylet or probechannel 92 configured and dimensioned to receive the stylet or probeshaft 18. As in the embodiment of FIGS. 1-3, the stylet or probe isinserted through stylet or probe channel 92 until the stylet or probe 18extends distally from the optical dilating obturator. With the opticaldilating obturator and cannula assembly withdrawn proximally up thestylet shaft, the stylet or probe is inserted, preferable under imageguidance, to a point adjacent to the target tissue. The optical dilatingobturator and cannula are then moved distally to dilate and spread thebrain tissue over the cannula. As the optical dilating obturator andcannula are advanced, the brain tissue being dilated may be visuallyobserved through the endoscope, preferably by displaying the image on amonitor or screen.

After the optical dilating obturator and cannula have been inserted todilate the brain tissue, the optical dilating obturator and stylet (ifused) are removed, leaving the cannula in place to permit the surgeon toperform surgery through the cannula.

FIGS. 7-11 illustrate the use of the access device 10 of the firstembodiment during minimally invasive brain surgery, as will now bedescribed.

In FIG. 7, a partial cross-section view of the access device 10 withprobe or stylet 16 inserted through an opening 100 formed in a patientsskull 102 through brain tissue until tip 24 of stylet 16 is adjacenttarget tissue 104. Opening 100 is made in a traditional manner, byincising the prepared and marked scalp, dissecting the scalp away fromthe underlying bony skull 102, retracting the scalp away from the areawhere hole 100 is to be formed, and then forming hole 100 using a drill,saw or similar apparatus in a known manner. After an opening has beenformed in the skull, the dura overlying and protecting the brain iscarefully incised and retracted to provide access to the brain. Stylet16 is approximately 12 cm to 15 cm in length and approximately 3 mm indiameter and may be atraumatically urged through brain tissue until thetarget tissue is reached. Because stylet handle 20 is associated withimaging targets 22 the position of the stylet may be confirmed one ormore times during insertion against pre-operative surgical planningimages using an image guidance system. As shown in FIG. 8, once stylet16 is placed, the dilating obturator with cannula is advanced carefullyalong the stylet so that the blunt rounded tip 30 atraumatically dilatesthe brain tissue. In FIG. 8, the dilating obturator is shown partiallyinserted into the brain, with blunt rounded tip 30 spreading the braintissue as the obturator is advanced.

In FIG. 9, the access device is shown inserted into brain tissue untilthe tip of the dilating obturator is adjacent the target tissue. Asshown, the brain tissue has been spread apart and surrounds cannula 12.With the access device fully inserted, the stylet and obturator areremoved, leaving the open cannula 12 to provide surgical access to thetarget tissue, as illustrated in FIG. 10. The brain tends to occupy thespace available within the skull and, as shown in FIG. 10, after theobturator is removed the target tissue will have a tendency to approachthe open end of the cannula. If this does not naturally occur it may bedesirable to separately advance the cannula forward either before orafter removing the dilator so that the end of the cannula is locateddirectly next to the target tissue.

After the access cannula is placed as shown in FIG. 10, surgery may beperformed upon the target tissue through the cannula. In this regard, itis contemplated that cannula lengths of up to about 6 cm may benecessary or desirable, although a cannula length of about 4 cm shouldbe sufficient to reach most areas of the brain where surgery is to beperformed using the access device and methods described herein. It isalso contemplated that the cannula may have an inner diameter ofapproximately 10 mm to 20 mm, and more preferably about 10 mm to 15 mmto allow multiple instruments, such as graspers, dissectors, scissors,and suction instruments to be inserted through the cannula to performsurgery. The cannula wall thickness may be on the order of from about 1mm to about 3 mm. In the event removal of tissue is desired, a debulkingsuction irrigation device such as a CUSA device (Valleylab, Inc.,Boulder Colo.) may be used. See, for example, Rose U.S. Pat. No.6,083,191; Stoddard U.S. Pat. Nos. 6,214,017, 6,256,859, and 6,654,999;and Cimino U.S. Pat. No. 6,602,227. Alternatively, a scissor andseparate suction tube may be used. In a preferred method of performingsurgery illustrated in FIG. 11, an endoscope of approximately 4 mmdiameter is partially inserted and held to one side of the cannula, andthe image of the end of the cannula and the target tissue is projectedonto a monitor for viewing by the operating surgeon, assistants andothers. Advantageously, a recording of the surgery also may be made. InFIG. 11, the endoscope 108 is illustrated inserted into the cannula 12and held in place by the arm 110 of a scope holding device, therebyeliminating the need for the surgeon or assistant to hold the scope.Endoscope 108 is attached to a source of illumination 112 by a lightcable 114. While the endoscope can be used under direct vision utilizingthe endoscope eyepiece, it is preferred to attach a camera 116 to theendoscope which in turn is attached via a cable 118 to a video device120 such as a VCR or DVD with an accompanying monitor display 122.Recent advances in operating room display equipment permit largemonitoring devices, such as flat panel displays to be used. The latterdisplay is particularly useful for teaching or lecturing purposes, as itallows multiple persons to observe the surgical technique. Without sucha display, it would be impractical to have numerous persons in theoperating field attempting to observe the surgery. Live telesurgery alsois contemplated. Also shown in FIG. 11 is a scissor 124 and suction tube126 being used to debulk and remove target tissue 104. Preferably, atall times during insertion of the access device into the brain andduring surgery through the cannula, the patient's brain function andcondition is monitored so that the surgeon may be alerted in the eventthe patient becomes distressed or otherwise is adversely affected by thesurgeon's actions. In the event signs of stress or adverse effects arenoted, the surgeon may decide to continue the surgery, wait to see ifthe patient stabilizes, or terminate the procedure. Because of thesensitive nature of brain tissue and associated nerves and bloodvessels, it is not uncommon for a surgeon to terminate a procedurebefore removing all target tissue in order to avoid the risk of seriousadverse effects upon the patient.

After surgery on the target tissue is complete, the instruments areremoved from the cannula. As the target tissue is removed, the braintissue fills the void formed by removing the target tissue so thathealthy brain tissue underlying the now removed target tissue isadjacent the end of the cannula, as shown in FIG. 12. The cannula isthen gently removed and the brain tissue naturally fills the spaceformerly occupied by the cannula, as shown in FIG. 13. This can takeseveral minutes, but is relatively atraumatic. The dura, skull and scalpare closed in a known manner.

It is contemplated that the cannula may be from about 2 cm to about 6 cmin length, although different lengths may be desirable for particularsituations. The cannula also preferably is clear, and is made to have asmooth outer surface to minimize trauma to the brain tissue. Animportant function of the cannula is to maintain the brain tissue in aseparated condition to provide access and room to perform surgery. Justas important, however, is the function of the cannula to protectsurrounding brain tissue from trauma due to contact with instrumentsduring surgery. Thus, the cannula performs the dual functions ofmaintaining working space created during insertion of the obturator andcannula assembly and protecting surrounding brain tissue from traumathat might otherwise be caused during surgery by contact with surgicalinstruments. Alternate cross-sectional shapes for the cannula andobturator also are contemplated, such as square, oval, or elliptical. Ofcourse, the dilating tip configuration may need to be altered in orderto provide atraumatic dilation of the brain tissue if such alternatecross-sections are used. The circular cross-section and rounded tip ofthe dilating obturator illustrated in the accompanying drawings has beenfound to be satisfactory, and permits gentle back and forth rotation tobe used during insertion to urge the blunt dissecting tip through thebrain tissue.

In all of the foregoing embodiments, it is also contemplated that theproximal end of the cannula may include an annular flange or collar, asshown in FIG. 21, to facilitate handling and to prevent the cannula fromadvancing into the brain during surgery.

In accordance with the above description, the dilating obturator andcannula may be placed using a guide stylet which has previously beenplaced into the brain under image guidance. Alternative techniques forplacing the stylet are contemplated. For example, rather than usingimage guidance, it is contemplated that the stylet may be placed using astereotactic headframe, such as a Leksell frame (Elekta, of Sweden) or aGTC frame (Radionics, Burlington, Mass.). In a further alternative usingsuch a headframe, the dilating obturator and cannula may be placed usingsuch a headframe and eliminating the need for the stylet. Suchstereotactic headframes and associated methods of approaching targettissue within the brain along a predetermined trajectory are shown anddescribed in Cosman U.S. Pat. No. 6,331,180.

In the further alternative embodiment shown in FIG. 4, the dilatingobturator equipped with image guidance means mounted directly to theobturator may be inserted under guidance without the use the stylet ofthe first embodiment. In using the embodiment of FIG. 4, the scalp andskull are opened in a traditional manner. Once access to the brain isestablished by opening and retracting the dura, dilating obturator 56with cannula 52 mounted onto shaft 60 is urged through the brain tissueso that the rounded semi-spherical tip of the obturator atraumaticallyspreads the brain tissue until the target tissue is reached. As thedilating obturator is advanced, the position of the obturator may bechecked using the image guidance system. Preferably, the obturator ispre-calibrated to the image guidance system. See, for example, CostalesU.S. Pat. No. 5,921,992. In this regard, it is also contemplated thatthe image guidance means could be mounted to the cannula, but such anapproach is less preferred because the image guidance means would remainattached to the cannula during surgery or the image guidance means wouldneed to be removed from the cannula prior to surgery, adding anotherstep to be performed. Attaching the image guidance means to theobturator accomplishes the objective of guiding placement of the cannulawhile also conveniently removing the image guidance means from thesurgical field with the obturator after the cannula is placed so thatthe image guidance means does not obstruct the operative field.

Current image guidance systems superimpose an image of the instrumentupon a pre-operative image of the patients skull. As imaging techniquesand equipment improve, it is contemplated that real time imaging will beavailable. Such real-time imaging techniques will be particularly usefulwith the techniques of the present method, as it will be possible toobserve the position of the dilating obturator in relation to thereal-time image of the brain structures rather than that by comparisonto pre-operative images. The infrared image guidance reflectors shown inthe first and second embodiments are used in connection with knownoptical image guidance systems. Such optical image guidance systemsrequire a direct line of site between the image guidance balls and thecamera of the image guidance system. While such optical image guidancemay be used in the surgical methods described herein, it is contemplatedthat magnetic image guidance also may be well suited for use in thepresent method. As the name implies, a magnetic image guidance systemuses magnetic forces to detect the position and orientation of theinstrument. Because no direct line of site is require, the magneticposition sensors may be detected even while positioned within the skull.It is therefore contemplated that one or more magnetic position sensorsmay be positioned at or near the tip of the dilating obturator so thatthe position of the tip may be more directly detected and displayed. Oneelectromagnetic guidance system is available from the VisualizationTechnologies division of GE Medical Systems. Compare Ferre U.S. Pat.Nos. 5,676,673, 5,800,352, 5,803,089, 5,829,444, 5,873,822, 5,967,980,6,175,756, 6,341,231, and 6,445,944.

While the preferred method utilizes image guidance to guide insertion ofthe dilating obturator and, hence, placement of the cannula, it isunderstood that it is possible to insert the dilating obturator withoutimage guidance. Thus, the third embodiment of FIG. 5 consists only of adilating obturator and cannula assembly without any associated imageguidance apparatus. In use, the dilating obturator 76 with cannula 72over the shaft 80 is inserted under direct visualization through braintissue until the blunt rounded, semi-spherical obturator tip is adjacentto the target tissue. An experienced surgeon also may find it useful toinspect pre-operative images displayed on the monitor simultaneous withinsertion of the obturator so that the surgeon may compare thepre-operative image to what is visible during insertion of the obturatorunder direct visualization. After the obturator and cannula of FIG. 5has been inserted, the obturator is removed as in prior embodiments toleave the cannula in place as shown in FIG. 10.

Thereafter, surgery is preformed through the cannula. After surgery, thecannula is removed and the dura, skull and scalp are closed in atraditional manner.

Referring now to FIGS. 14-16, an alternative structure for creatingsurgical access is shown. In this embodiment, an expandable sleeve 200is mounted to a sleeve hub 202, such as by capturing the end of thesleeve between two parts of the hub which are snapped or welded togetherduring assembly. As shown in FIG. 14A, which is a cross-section viewtaken along lines 14A-14A of FIG. 14, hub 202 has a bore 204 configuredand dimensioned to allow a dilating obturator and cannula assembly to beinserted through the hub into the expandable sleeve 200. A stylet orprobe 216 having a shaft 218 is inserted through the hub bore 204 andthrough the sleeve 200 with sleeve 200 in an unexpanded state. Stylet216 preferably includes a handle 220 and image guidance reflectors 222similar to the embodiment shown in FIGS. 1-3. By way of example only,sleeve 200 may have an outer diameter on the order of 3 mm to 4 mm withthe stylet shaft 218 inserted therethrough.

Referring to FIG. 15, in use stylet shaft 218 with sleeve 200 mountedthereon is inserted through bore hole 100 in the skull 102 into thebrain until tip 224 of shaft 218 is adjacent target tissue 104,preferably using image guidance.

As shown in FIG. 16, after the expandable sleeve is inserted adjacenttarget tissue 104, stylet 216 is withdrawn, leaving expandable sleeve200 in place. Thereafter, dilating obturator and cannula assembly 226 isinserted through bore 204 in hub 202, such that the blunt dilating tip230 of the dilating obturator, which may be conical, rounded,semi-spherical (as shown) or other suitable atraumatic shape, spreadsthe expandable sleeve 200 to dilate the brain tissue and receive cannula228. Once the obturator and cannula assembly 230 has been inserted, thedilating obturator 232 is removed, leaving cannula 228 surrounded byexpandable sleeve 200 in place to provide access to target tissue 104for surgery to be performed as previously described, as shown in FIG.17.

In an alternative configuration shown in FIG. 18, dilating obturator 332is provided with a longitudinal channel 334 configured and dimensionedto receive stylet or probe shaft 318. In this embodiment, the dilatingobturator and cannula assembly is pre-mounted to the stylet or probeshaft 318. Shaft 318 is of sufficient length to accommodate both theexpandable sleeve assembly and the dilating obturator/cannula assemblyin stacked end to end relation. In use, the stylet shaft 318 with thesurrounding sleeve is inserted into the brain under image guidance(reflectors 322 allow orientation of the entire assembly under imageguidance). Once the stylet and sleeve are placed, the dilating obturatorand cannula assembly may be slid distally over the stylet shaft 318 sothat sleeve 200 expands over the dilating tip and cannula, gentlyspreading the brain tissue sufficiently to receive cannula 328. This maybe accomplished by holding hub 302 in one hand and obturator handle 326in the other, and moving the obturator distally while maintaining theposition of the stylet and expandable sleeve. An advantage of thisconfiguration is that the position of the stylet tip 324 relative totarget tissue 104 may be confirmed under image guidance at one or moreintervals as the dilating obturator and cannula assembly is insertedinto the expandable sleeve, thereby assuring proper cannula placement.Alternative configurations are contemplated. For example, image guidancereflectors may be mounted to the dilator to be used with the embodimentshown in FIG. 16 either in addition to or in place of image guidancereflectors on the stylet or probe assembly. It is also contemplated thatthe optical dilating obturator of FIGS. 6A-6B may be used with theexpandable sleeve embodiments of FIGS. 14-18.

In yet a further embodiment of the expandable sleeve approach shown inFIGS. 19A and 19B, the cannula may be inserted in collapsed segmentscontained within the expandable sleeve and inserted together with thestylet and expandable sleeve. A radial force is applied to urge thecannula wall segments radially outward, thereby expanding the expandablesleeve and establishing the full cannula opening. The cannula wallsegments lock in place in a manner similar to a Roman arch to supportthe expanded sleeve and create a working space. The radial force toexpand the cannula segments may be created by a balloon, which desirablymay be collapsed to a very low profile and yet may create the desiredradial force to expand the sleeve, dilate the brain tissue and lock thecannula wall segments in place. Alternatively, coil or spring structuresmay be used to create the desired radial force to expand the sleeve andcannula.

Referring to FIGS. 19A and 19B, an example of a balloon expandedcannula/sleeve assembly is shown in cross section at a point along theshaft of the expandable sleeve device. As shown in FIG. 19A, styletshaft 418 is at the center of the structure, surrounded in radiallyoutward order by a collapsed balloon 440, overlapping cannula wallsections 430 and expandable sleeve 400. All components extend the lengthof the expandable sleeve. The tip of stylet shaft 418 is inserted intobrain tissue until the stylet tip and, hence, the distal end of theexpandable sleeve is placed adjacent the target tissue, preferably usingimage guidance. Balloon 440 is expanded, such as by being filled underpressure with saline. The pressure created in the balloon forces thecannula wall segments 430 radially outward until the wall segments lockin place. See FIG. 19B. As the cannula wall segments are moved radiallyoutward and lock into place, expandable sleeve 400 is in turn expandedoutward to dilate surrounding brain tissue. Once the cannula walls arelocked out, the balloon may be deflated and the stylet and balloonremoved, leaving an open cannula to access and perform surgery on targetbrain tissue.

The radial expanding sleeve may provide advantages in performing brainsurgery. First, because longitudinal force is not utilized to expand thesleeve, there is less likelihood that the expandable sleeve willinadvertently be advanced further into the brain during expansion.Furthermore, because radial force is generated along the length of thestylet and cannula, no blunt dilating tip extends beyond the cannulaafter dilating brain tissue, as may occur with the use of a longitudinaladvancement of a dilating obturator.

Referring now to FIGS. 20A and 20B, an alternative structure forradially expanding sleeve 400 is shown in which shortening the length ofan expanding structure 442 radially expands sleeve 400. As shown in FIG.20A, in a first position expanding structure 42 has a first braid angleand a relatively small radial width. As shown in FIG. 20B, with thedistal end of expanding structure 442 constrained against longitudinalmovement, such by tethering the end of the braided structure, theproximal end of the braid is urged distally so that the braid shortens.The distal end of the braid could be tethered, for example, by aplurality of longitudinally extending wires or filamentscircumferentially disposed around the braid running the length of thebraid to the distal end thereof. As the braid is shortened, the braidangle decreases and the diameter of the braid increases, therebyexpanding the sleeve to create the desired diameter of sleeve forworking access to the target tissue. Because the force required todilate brain tissue is relatively low, shortening the braid may developsufficient force to radially expand the sleeve, and consequently thesurrounding brain tissue. It is also contemplated that the approach ofshortening a braid to create radial force could be used to open cannulasegments 430 (see FIGS. 19A and 19B) to their open, locked position.

In all of the foregoing embodiments the surgeon is provided an opencannula to access target tissue within the brain. Advantageously, theopen cannula is placed atraumatically which may allow surgery to beperformed deeper in the brain or in areas of the brain previouslybelieved to be inaccessible without high risk of advance consequencesfor the patient.

Numerous modifications and additions to the embodiments shown ordescribed herein will become apparent to those skilled in the art basedon this disclosure, and the disclosure is not intended to be limitingwith respect to such additions or modifications. By way of example,although not shown it is contemplated that the proximal end of thecannula in all embodiments may be mounted to a housing or handle tofacilitate control and movement of the cannula. By way of furtherexample, such a cannula housing could couple to the expandable cannulahousing (see FIGS. 14-18) to positively position the cannula withrespect to the expandable sleeve housing and, hence, the expandablesleeve.

The techniques described herein are particularly useful to accesstumors, cysts or other conditions which might otherwise be consideredinoperable or might require much more invasive transcranial surgery toremove a larger portion of the skull and retract a substantial amount ofbrain tissue. The techniques described herein using dilating obturatorand cannula permit brain surgery to be performed in a less invasivemanner through an opening in the skull that is substantially smallerthen otherwise possible, on the order of a 2 cm to 4 cm in diameterrather than a much larger opening for more traditional surgicaltechniques.

What is claimed is:
 1. A surgical access device for brain surgery, thesurgical access device comprising: an obturator having a proximalobturator end, a distal obturator end and an obturator shaft extendingbetween the proximal obturator end and the distal obturator end, thedistal obturator end comprising a transparent window forming anatraumatic blunt dilating tip; a cannula having a proximal cannula endand a distal cannula end and a longitudinal access channel extendingfrom the proximal cannula end to the distal cannula end, the cannulabeing configured and dimensioned to removably mount over the obturatorshaft with the proximal cannula end adjacent the proximal obturator end,and the distal obturator end extending outside the distal cannula end;and an image guidance identification device comprising image guidancereflectors attached to and located outside the obturator and configuredto indicate the position of the surgical access device to an imageguidance system to allow insertion of the surgical access device intissue under guidance without requiring insertion of a stylet in advanceof the surgical access device.
 2. The surgical access device of claim 1,wherein the distal cannula end comprises a chamfered leading edge. 3.The surgical access device of claim 1, wherein the cannula comprises atransparent material.
 4. The surgical access device of claim 1, whereinthe cannula is cylindrical.
 5. The surgical access device of claim 1,wherein the proximal obturator end comprises a handle portion.
 6. Thesurgical access device of claim 5, wherein the handle portion is largerthan the longitudinal access channel to prevent the cannula from slidingover the proximal obturator end.
 7. The surgical access device of claim6, wherein the image guidance identification device is mounted to thehandle portion.
 8. The surgical access device of claim 1, wherein theatraumatic blunt dilating tip comprises a rounded surface.
 9. Thesurgical access device of claim 1, wherein the atraumatic blunt dilatingtip comprises a semi-spherical surface.
 10. The surgical access deviceof claim 1, wherein the obturator comprises a longitudinal obturatorchannel extending to the atraumatic blunt dilating tip.
 11. The surgicalaccess device of claim 1, wherein the longitudinal obturator channel isconfigured and dimensioned to receive an endoscope.
 12. The surgicalaccess device of claim 1, wherein the obturator does not include anaccess channel through the atraumatic blunt dilating tip.
 13. Thesurgical access device of claim 1, wherein the obturator furthercomprises a longitudinal stylet channel that is configured anddimensioned to receive a stylet.
 14. The surgical access device of claim1, wherein the obturator shaft is cylindrical.
 15. The surgical accessdevice of claim 1, wherein the image guidance identification device ismounted directly to the obturator.
 16. The surgical access device ofclaim 1, wherein the image guidance identification device is mounted tothe proximal obturator end.
 17. The surgical access device of claim 1,wherein the image guidance reflectors comprise infrared reflectors. 18.The surgical access device of claim 17, wherein the infrared reflectorscomprise three infrared reflectors.
 19. The surgical access device ofclaim 1, wherein the obturator is pre-calibrated to an image guidancesystem.
 20. The surgical access device of claim 1, wherein the imageguidance identification device is removable from the cannula with theobturator.